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Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Groin Surgery

NCT ID: NCT00970086

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-11-30

Brief Summary

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For surgery in the region of the lower abdominal wall the administration of local anesthetic drugs in the epidural space via the caudal route is the preferentially used technique since several decades.

The transversus abdominis plane (TAP) block features the advantages of a peripheral nerve blockade. The aim of this study is to evaluate potential differences in the effectiveness of postoperative analgesia and to test the hypotheses that the duration of pain relieve ist prolonged after a TAP block when compared with an epidural technique.

Detailed Description

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Caudal block (CB) is the gold standard technique for analgesia in children undergoing surgical interventions in the groin.

Although the efficacy and the safety of this technique is high, nonetheless, there are several caveats such as unwarranted motor blockade of the lower limbs and disturbances of the bladder function, potentially resulting in delayed demission in the ambulatory setting. The effect of the blockade wears off within 4-5h post-block, making the administration of additional pain medication necessary.

Peripheral nerve blockades (PNB) are an alternative to CB and have a prolonged duration of the analgesic effect. More recently, an alternative method to block neural structures which innervate lower abdominal wall has been described; the transverse abdominal plane block. The ultrasound guided technique improves the safety of margin. However, although this new technique seems to offer substantial advantages so far only experience from small case series are available. In particular, the TAP block has not been compared in a systematic trial with the "gold standard", the caudal block.

Conditions

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Postoperative Pain Reaction; Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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transversus abdominal plane block

Caudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%.

Transversus abdominal plane block: Identification of the anatomical structures with ultrasound, insertion of the stimuplex needle G22, 50mm, in an in-plane approach and administration of 0.4ml/kg levobupivacaine 0.25%.

Group Type EXPERIMENTAL

Bupivacain/levobupivacaine

Intervention Type DRUG

Caudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%.

Transversus abdominal plane block: Identification of the anatomical structures by the ultrasound technique, administration of 0.4ml/kg levobupivacaine 0.25%.

Interventions

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Bupivacain/levobupivacaine

Caudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%.

Transversus abdominal plane block: Identification of the anatomical structures by the ultrasound technique, administration of 0.4ml/kg levobupivacaine 0.25%.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female children aged 2 - 8 years
* physical status classification system (ASA) score I or II
* Undergoing surgical interventions in the groin (hernia repair, funiculocele ectomy)

Exclusion Criteria

* Hypersensitivity to Levobupivacaine
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Erb, PD

Role: PRINCIPAL_INVESTIGATOR

University Childrens Hospital of both Basel

Locations

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University Childrens Hospital of both Basel

Basel, Basel, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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UKBB_ANA_TAP

Identifier Type: -

Identifier Source: org_study_id